The U.S. Food and Drug Administration late Thursday afternoon issued an emergency use authorization to Eli Lilly and Co. to allow use of its drug baricitinib in combination with the drug remdesivir to treat COVID-19.
The drug combination can be used in hospitalized adults and pediatric patients 2 years or older requiring oxygen or invasive mechanical ventilation.
The FDA made the announcement shortly before 5 p.m.
In a clinical trial of hospitalized patients with Covid-19, baricitinib, in combination with remdesivir, was shown to reduce recovery time.
In addition, the combination reduced the death rate by up to 33% according to information released by the FDA. The FDA said the safety and effectiveness of this investigational therapy for use in the treatment of Covid-19 continues to be evaluated.
Baricitinib is not authorized or approved as a standalone treatment for Covid-19.
“Today”™s action demonstrates the FDA”™s steadfast efforts to make potential Covid-19 treatments available in a timely manner, where appropriate, while continuing to support research to further evaluate whether they are safe and effective,” FDA Commissioner Stephen M. Hahn said.
Baricitinib is a prescription oral tablet medication that is already FDA-approved and sold under the brand name Olumiant for the treatment of moderately to severely active rheumatoid arthritis.
Remdesivir is an FDA-approved drug sold under the brand name Veklury. It is a drug given to President Trump when he was hospitalized for Covid treatment. Remdesivir also remains authorized for emergency use for the treatment of certain adult and pediatric Cover patients.
“The FDA”™s emergency authorization of this combination therapy represents an incremental step forward in the treatment of COVID-19 in hospitalized patients, and FDA”™s first authorization of a drug that acts on the inflammation pathway,” said Patrizia Cavazzoni, acting director of the FDA”™s Center for Drug Evaluation and Research.
“Despite advances in the management of COVID-19 infection since the onset of the pandemic, we need more therapies to accelerate recovery and additional clinical research will be essential to identifying therapies that slow disease progression and lower mortality in the sicker patients.”
